Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
- Peripheral T-Cell Lymphoma, Not Otherwise Specified
- Angioimmunoblastic T-cell Lymphoma
- Follicular T-Cell Lymphoma
- Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
- Systemic Anaplastic Large Cell Lymphoma
- Lymphoma, T-Cell, Peripheral
- Lymphoma, T-Cell
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Corvus Pharmaceuticals, Inc.
- Enrolment target
- 150
- Started
- 2 October 2024
- Main results due
- November 2027
- Study sites
- 37
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 1. Adult participants ≥18 years of age on the day of signing the informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms. 4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies. 5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist. 6. Life expectancy \>12 weeks. 7. Adequate organ function as determined by: * Absolute neutrophil count ≥ 1.0×10\^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor) * Platelet count ≥ 100×10\^9/L (without transfusion) * Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug * Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) * Serum albumin \> 2.5 g/dL * Serum calcium \< 12 mg/dL or corrected serum calcium \< ULN 8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following: * Grade ≤ 2 neuropathy * Alopecia and non-acute toxicities * If major received major surgery, then must have recovered adequately per the investigator from the toxicity and/or complications from the intervention prior to starting study treatment 9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate. 10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug. Exclusion Criteria: 1. Participants who have T-cell lymphoma with active central nervous system involvement. 2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. 3. History of primary immunodeficiency or sold organ transplantation. 4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy. 5. Any active infection requiring IV therapy. 6. History of invasive prior malignancy that required systemic therapy within last 3 years. 7. Any condition that confounds the ability to interpret data from the study. 8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\]) or positive test for hepatitis C antibody. 9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment. 10. Prior administration of an ITK inhibitor. 11. Participants who need immediate cytoreductive therapy. 12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment. 13. History of allogeneic hematopoietic stem cell transplantation. 14. Candidate for hematopoietic stem cell transplantation at screening. 15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation. 16. Concurrent enrollment in another clinical study 17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment. 18. Participants who cannot ingest medications orally or who have malabsorption.
What this study is about
In the sponsor’s own words, from the registry.
A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).
Study sites(37)
City of Hope National Medical Center
Duarte, California, United States
Recruiting
University of California, Irvine
Irvine, California, United States
Recruiting
University of California San Francisco
San Francisco, California, United States
Recruiting
Yale University
New Haven, Connecticut, United States
Recruiting
Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine
Miami, Florida, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC
Chicago, Illinois, United States
Recruiting
University of Iowa
Iowa City, Iowa, United States
Recruiting
University of Maryland Medical Center
Baltimore, Maryland, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Roger Cancer Center University of Michigan Health
Ann Arbor, Michigan, United States
Recruiting
Washington University in St. Louis
St Louis, Missouri, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Weill Cornell Medicine
New York, New York, United States
Recruiting
North Carolina Cancer Hospital
Chapel Hill, North Carolina, United States
Recruiting
The Ohio State University
Columbus, Ohio, United States
Recruiting
Oregon Health & Science University; Knight Cancer Institute
Portland, Oregon, United States
Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
University of Washington Fred Hutch Cancer Center
Seattle, Washington, United States
Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Recruiting
St George Hospital
Kogarah, New South Wales, Australia
Recruiting
ICON Cancer Centre
South Brisbane, Queensland, Australia
Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Recruiting
Flinders Medical Center
Bedford Park, South Australia, Australia
Recruiting
Royal Hobart Hospital
Hobart, Tasmania, Australia
Recruiting
Box Hill Hospital
Box Hill, Victoria, Australia
Recruiting
Austin Hospital
Heidelberg, Victoria, Australia
Recruiting
Epworth Healthcare
Richmond, Victoria, Australia
Recruiting
Linear Clinical Research
Perth, Western Australia, Australia
Recruiting
BC Cancer Research Institute
Vancouver, British Columbia, Canada
Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Recruiting
The Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting
Showing 37 of 37 sites. 37 of the 37 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06561048. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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